JMIR Publications

ABSTRACT

Background:

Limited public understanding of randomized controlled trials (RCTs) hinders recruitment, retention, and confidence in research. Early exposure to trial concepts may strengthen health literacy and research engagement. The Kid’s Trial was a global, decentralized, child-led study that co-created and conducted an RCT to help children understand trials, their importance, and improve critical thinking.

Objective:

This paper presents its design, outcomes, and methodological reflections.

Methods:

The Kid’s Trial employed a dedicated website with study materials guiding children through each step of designing and conducting an RCT. Each step was linked to an online survey. Materials were co-developed with two patient and public involvement groups of children and parents. Any child, aged 7 to 12 years, could take part in as many or as few steps as desired. Recruitment combined online and offline strategies, and engagement and self-reported learning were descriptively analyzed. The co-created REST (Randomized Evaluation of Sleeping with a Toy or Comfort Item) trial was a two-arm, pragmatic RCT comparing one week of sleeping with versus without a comfort item. The primary outcome was sleep-related impairment, and the secondary outcome was overall sleep quality. Analyses followed an intention-to-treat approach using mixed-effects models adjusted for baseline measures.

Results:

Overall, 224 children from 15 countries participated in at least one step. Participation varied: 37% (n = 82) completed one step and 21% (n = 48) completed six. The REST trial randomized 139 children, with 73% (n = 101) completing outcome surveys. Adjusted mean differences (intervention–control) were −0.53 for sleep-related impairment (95% CI −3.40 to 2.34; P=.71) and 0.28 for sleep quality (95% CI 0.01 to 0.55; P=.04), a small, uncertain difference not supported with sensitivity analyses. Post-study responses (n = 20) indicated improved understanding of RCT concepts.

Conclusions:

The Kid’s Trial demonstrates the feasibility of a decentralized, child-led RCT co-created through participatory citizen-science methods. Children can meaningfully contribute to trial design and conduct, and experiential participation may foster early trial literacy and critical thinking. Future studies should enhance engagement through community partnerships, shorter intervals between steps, and embedded learning assessments to improve inclusivity and retention.